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Retrievable Inferior Vena Cava Filter
A retrievable inferior vena cava filter, also known as an IVC filter, is a small device made of metal materials that is designed to stop a blood clot from traveling to the lungs (pulmonary embolism).
The largest vein in the human body is the inferior vena cava. Its job is to move de-oxygenated blood from the lower legs to the heart and then the lungs. To prevent blood clots from traveling through the vein into the lungs, an IVC filter is implanted in the inferior vena cava of patients who have a history, or are at risk of, developing blood clots in the legs, including patients:
- diagnosed with deep vein thrombosis
- with pulmonary embolus.
- who are trauma victims.
- who are immobile.
- who have recently had surgery or delivered a baby
There are two subgroups of nonpermanent filters: temporary filters which are filters that must be retrieved, and retrievable filters, which can be retrieved after implantation. Temporary filters are tethered to the skin by a catheter for short-interval retrieval but are no longer available in the United States.
Retrievable filters are a hybrid between permanent and temporary in that they aim to offer the benefits of permanent filters for a limited duration but also maintain the option to be left in a patient as a permanent device because many designs were initially approved for permanent placement. However, the FDA reported concern about the devices staying in patients long after pulmonary embolism risks subsided. The FDA updated safety communication in 2014, recommending retrievable devices be removed between the 29th and 54th day after implantation in patients in which pulmonary embolism risks passed.
An IVC filter is cleared for use by the FDA after a manufacturer submits a Premarket Notification or 510(k), which notifies the FDA of the intent to market a medical device. The FDA approved the device in 1979, and its use increased continuously through the years. By 2012, doctors inserted approximately 259,000 filters in patients.
There are many manufacturers of IVC filters including;
- ALN Implants Chirurgicaux
- Argon Medical Devices, Inc.
- Cook Incorporated
- Cordis Corporation
- Johnson & Johnson
One of the most prominent manufacturers of retrievable IVC filters is C.R. Bard. The New Jersey-based company created the Bard Recovery IVC filter. The Recovery filter initially received FDA approval in 2002. However, soon after its release reports of injury and death were recorded. The primary issues were that the device itself moved (also called, migration) while implanted in a patient’s body. A study was arranged and it was found that the filter created a significantly higher risk of injury and death in patients compared to other IVC filters available on the market.
The Recovery filter continued to be sold until 2005 when C.R. Bard received FDA approval for its G2 filter. The G2 was supposed to limit the risk of fracture and migration that had been seen in the Recovery filter but the company issued an internal memo which noted problems continued to manifest within the new device. This meant that the company continued to sell the filter while having knowledge that serious issues existed.
Retrievable IVC filters can cause several complications like:
- Blood vessel and organ perforation – Retrieval of temporary filters carries a risk of perforation or rupture of the IVC after extended implantation when portions of the filter may be well incorporated into the vessel wall.
- Filter migration – IVC filters can migrate from the deployed position to another part of the IVC, to the heart, or to the pulmonary outflow tract.
- Filter fracture – A recently conducted study of IVC filters found that about 25% caused the device to fracture or break apart.
The FDA has not at this time ordered a recall of retrievable IVC filters. However, the FDA has issued a recommendation to doctors advising them to remove retrievable IVC filters as soon as the protection from pulmonary embolism is no longer needed. The thought is that doing so may reduce the risk of complications.
The FDA also issued manufacturer, C.R. Bard, a warning letter for mis-branding violations for some of its devices including, the Recovery Cone Removal System Model RC-15. The FDA found that C.R. Bard’s manufacturing facility found quality system violations pertaining to the receipt, review, and evaluation of product-related complaints. For example, C.R. Bard filed the death of a patient implanted with a detached filter arm of a G2 IVC filter that had embolized with associated areas of hemorrhage and necrosis in the right lung as merely a product malfunction instead of as a death. This was a common occurrence where Bard filed serious injuries as malfunctions rather than as an actual issue with the device.
A lawsuit was later filed against C.R. Bard by a patient who claimed that the small IVC filter broke inside his body and perforated his heart. Ultimately the case was settled out of court. Since that time, three class-action lawsuits have been filed against C.R. Bard in Florida, Pennsylvania and California courts by claimants who received Bard IVC filters. The lawsuits claim that the Bard Recovery, G2 and G2 Express filters that have not yet fractured or migrated must receive medical monitoring because of the manufacturer’s negligence, misrepresentation and concealment of data.